Company: Zyno Medical LLC
Date of Enforcement Report: 6/6/2025
Class: I
PRODUCT
Z-800 Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient.
Recall Number:
Z-1865-2025
REASON:
Unreleased software versions were installed on distributed devices without verification or validation.
RECALLING FIRM/MANUFACTURER:
Zyno Medical LLC
VOLUME:
613 units
DISTRIBUTION:
US Nationwide
